Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients
- Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor
lysate-pulsed dendritic cells after surgical resection in pediatric patients with
- Determine the maximum tolerated dose of this vaccine in these patients.
- Determine, preliminarily, the survival of patients treated with this vaccine.
- Determine, preliminarily, the time to tumor progression in patients treated with this
- Determine cellular immune response in patients treated with this vaccine.
- Determine age-dependent differences in response to this vaccine, in terms of
immunocompetence, in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate.
Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for
generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous
dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive
vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14,
and 28 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vaccine until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 2 weeks and then every 2
months for 1 year.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
Joseph L. Lasky, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|